On May 13, 2021 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported new collaborations in Israel, Italy and Spain to expand molecular screening opportunities for patients with cancers that may have neuregulin 1 (NRG1) fusions and to raise awareness of the Merus eNRGy clinical trial of its bispecific antibody zenocutuzumab (Zeno) (Press release, Merus, MAY 13, 2021, View Source [SID1234579953]). In the collaborations, Merus plans to support molecular screenings for eligible patients with pancreatic adenocarcinoma in Israel and Italy, and with non-small cell lung cancer (NSCLC) in Spain, aimed to identify the presence of NRG1 fusions. Each collaborating organization in turn has agreed as follows:
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Progenetics, Ltd. plans to perform a nationwide campaign in Israel to raise awareness of the molecular screening offered by Merus for eligible pancreatic adenocarcinoma patients and availability of the eNRGy trial for eligible patients. Progenetics is a leading Israeli company in oncology testing, currently distributing diagnostic tests for nine American companies in the field of onco-diagnostics.
Italian Association for the Study of Pancreas (AISP) plans to inform their nationwide network of oncologists, pancreatic cancer patients and patient associations in Italy of the molecular screening offered by Merus for eligible pancreatic adenocarcinoma patients and availability of the eNRGy trial for eligible patients.
Dr. Michele Reni, a Principal Investigator on the eNRGy trial and physician at the San Raffaele Scientific Institute in Milan, has agreed to facilitate the collaboration with AISP and said, "Our collaboration with Merus, and the testing they are supporting, offers a unique opportunity to our patients and to physicians involved in the treatment of pancreatic cancer to help patients know their NRG1 fusion status and to potentially match patients with clinical trial opportunities that specifically target their unique tumor profiles."
Universidad de Navarra plans to provide Merus-funded molecular screening to eligible patients with NSCLC, through the Clínica Universidad de Navarra network in Spain, which may identify NRG1 fusions, and plans to inform patients with NRG1-fusion-positive cancer of their potential eligibility for the eNRGy trial. The Clínica Universidad de Navarra, based in Pamplona and Madrid, is a leading research hospital in Spain. A recognized institution for both its teaching and research work, and its trajectory in the diagnosis and treatment of highly complex pathologies, the Clínica Universidad de Navarra is characterized by the diagnostic speed achieved through multidisciplinary work and the acquisition of the latest technology to offer care in 46 different medical and surgical specialties.
"These latest collaborations expand Merus’ global efforts to raise awareness of the importance of molecular testing which can lead to potentially better treatment and clinical trial options for cancer patients," said Dr. Andrew Joe, Chief Medical Officer of Merus. "Merus’ support in the screening of these patients is also a strategic effort to potentially identify and recruit patients with cancer harboring NRG1 fusions for our eNRGy trial."
Merus has implemented a global approach designed to increase access to molecular screenings for cancer patients and to potentially enhance enrollment in the eNRGy trial by working with private industry, country-specific testing organizations, cooperative groups and disease-specific cancer organizations. Increasing access to molecular screenings may help oncologists and their patients, whose cancers may not be screened routinely for gene mutations, make informed decisions on what treatment and clinical trial options may be available.
With the addition of these collaborations announced today, Merus is now working with more than ten different industry and academic collaborators across Asia, North America and Europe aimed to enhance testing for NRG1 fusions and to raise awareness of the eNRGy trial.
About the eNRGy Clinical Trial
Merus is currently enrolling patients in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of zenocutuzumab (Zeno) monotherapy in NRG1+ cancers. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ other solid tumors. Further details, including current trial sites, can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com or by calling 1-833-NRG-1234.
About NRG1 Fusions
The NRG1 gene encodes neuregulin (also known as heregulin), the ligand for HER3. Fusions between NRG1 and partner genes are rare, tumorigenic genomic events occurring in patients with certain cancers.
About Zeno
Zenocutuzumab (Zeno) is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 gene fusions (NRG1+). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancers. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions. Learn more about Zeno Dock & Block at View Source